PE ZD
High-tech cleanrooms
TBMC cleanroom turnkey

Taiwan and Asia

High-tech cleanrooms

Laboratories, Pilot Plants, Manufacturing: Design-Build, Qualification & Validation.

For biopharma, semiconductors, and hospitals. Pharmaceutical GMP practice, carried out by a Taiwan team across Asia.

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Particle class · ISO 9 → ISO 7 → ISO 5

TBMC cleanroom turnkey

Projects

Projects

微生物實驗室
微生物實驗室
Confidential Turnkey
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 注射小針產線
注射小針產線
Confidential Turnkey
—Area
—Duration
—Class
 臨床GxP工程
臨床GxP工程
Confidential Turnkey
—Area
—Duration
—Class
 改建評估工程
改建評估工程
Confidential Turnkey
—Area
—Duration
—Class
 冷藏庫確效
冷藏庫確效
Confidential Qualification & Validation
—Area
—Duration
—Class
 2000L 生物製劑廠改建工程​
2000L 生物製劑廠改建工程​
Confidential Turnkey
—Area
—Duration
—Class
 動物製劑廠改建工程
動物製劑廠改建工程
Confidential Turnkey
—Area
—Duration
—Class
 保健食品改建工程
保健食品改建工程
Confidential Turnkey
—Area
—Duration
—Class
 All projects →

Design-Build, Qualification & Validation

Design

URS to DQ: cleanliness grade, flows, and differential pressure are fixed before construction starts.

Engineering

Cleanroom, HVAC, and utilities installed together, including renovation while production continues.
ΔP

Qualification & Validation

The same team performs TAB, IQ, OQ, and PQ.

Pressure cascade

An ISO 7 plant: gowning, corridor, then the graded rooms. Design, engineering, and the tests sit on one drawing.

Airlock, gowning, and hand disinfection.

Recorded results

2,017 Founded
17 Published projects
20,000 Largest single area m²
5 Shortest design to qualification and validation (months)

Each project names its own result: PIC/S GMP, TFDA, and others only when that record has them.

Demo

EVMS Environmental Validation and Monitoring System

Temperature, humidity, and differential pressure are monitored continuously. The figures here are a demonstration, not an operating plant.

22.4°C · 48% RH · +15 Pa · Demo

ΔP alarm · Demo

Grade C −2 Pa / 00:14

EVMS section

PE ZD’s scope

Turnkey delivery, public-project controls, consulting, and qualification and validation are carried by the team that designs the facility.

PE ZD Engineering Co., Ltd.

Turnkey Design-Build and C&Q. Public-project PCM. Consulting, project management, and qualification and validation for laboratories, pilot plants, and manufacturing that must hold a cleanliness grade.

From the requirements interview to completed qualification and validation

  1. 01Interview / URS
  2. 02Concept and quote
  3. 03Design
  4. 04Engineering
  5. 05TAB / C&Q
  6. 06Handover and monitoring

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